510(k) Report

510(k) · Cleared

Recalled · 2007

Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205

K003323510(k) TraditionalCleared Jan 22, 200190-day reviewClass II21 CFR 878.3300Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Davol, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Jan 22, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 44 later devices descend from it. It has been recalled 3 times.

Decided
Jan 22, 2001
Review
90 days
Class
Class II
Product code
FTL
Recalls
3
Predicates
0

44 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2006: 2 descendants cleared2011: 3 descendants cleared2018: 3 descendants cleared2008: 3 descendants cleared2014: 6 descendants cleared2012: 3 descendants cleared2013: 4 descendants cleared2015: 4 descendants cleared2010: 1 descendant cleared2022: 2 descendants cleared2019: 3 descendants cleared2025: 3 descendants cleared2024: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant cleared2021: 1 descendant cleared2026: 1 descendant cleared2020: 1 descendant cleared200020052010201520202025
  1. This deviceK003323 Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205Davol, Inc. · 2001
  2. Descendant · cites it directly · 31 of its ownK050187 Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production · 2005
  3. Descendant · 2 generations on · 15 of its ownK062915 Veritas Collagen MatrixSynovis Surgical Innovations · 2006 · Recalled
  4. Descendant · cites it directly · 15 of its ownK061314 Bard Extra Large Composix Kugel Hernia PatchDavol Inc., Sub. C. R. Bard, Inc. · 2006
  5. Descendant · 2 generations on · 14 of its ownK110816 Parietex Optimized Composite Mesh (Pco-Osx References)Sofradim Production · 2011
  6. Descendant · 2 generations on · 14 of its ownK081777 Ventrio Hernia PatchC.R. Bard, Inc. · 2008 · Recalled

Showing 5 of 44 descendants. See all descendants

Descendants cleared per year

2005: 12006: 22008: 32010: 12011: 32012: 32013: 42014: 62015: 42016: 12017: 12018: 32019: 32020: 12021: 12022: 22024: 12025: 32026: 1
2005high 6 (2014) · low 0 (2007)2026

Most influential descendants

Showing 5 of 44 · See all
  • K050187Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production · 2005 · cites it directly31descendants
  • K062915Veritas Collagen MatrixSynovis Surgical Innovations · 2006 · 2 generations on15descendants
  • K061314Bard Extra Large Composix Kugel Hernia PatchDavol Inc., Sub. C. R. Bard, Inc. · 2006 · cites it directly15descendants
  • K110816Parietex Optimized Composite Mesh (Pco-Osx References)Sofradim Production · 2011 · 2 generations on14descendants
  • K081777Ventrio Hernia PatchC.R. Bard, Inc. · 2008 · 2 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003323Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205Davol, Inc.2001—
+1K050187Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production2005—
+2K062915Veritas Collagen MatrixSynovis Surgical Innovations20061
+1K061314Bard Extra Large Composix Kugel Hernia PatchDavol Inc., Sub. C. R. Bard, Inc.2006—
+2K110816Parietex Optimized Composite Mesh (Pco-Osx References)Sofradim Production2011—
+2K081777Ventrio Hernia PatchC.R. Bard, Inc.20084

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200620
200830
201010
201130
201230
201340
201460
201540
201610
201710
201830
201930
202010
202110
202220
202410
202530
202610
FIG. 1 — Lineage of K003323, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FTL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FTL device

  1. #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (44)

See all 44

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K050187Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production200531
K061314Bard Extra Large Composix Kugel Hernia PatchDavol Inc., Sub. C. R. Bard, Inc.200615

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 10, 2007Not classifiedZ-0359-2007OtherPET recoil ring breakage-Memory recoil ring may break which could potentially lead to bowel perforation and or chronic enteric fistula
Jan 10, 2007Not classifiedZ-0360-2007OtherPET recoil ring breakage-Memory recoil ring may break which could potentially lead to bowel perforation and or chronic enteric fistula
Dec 22, 2005Not classifiedZ-0524-06OtherMemory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K050187 (Sofradim Production, 2005) has gone furthest, with 31 descendants of its own.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FTL

6in 2025

2007: 202008: 232009: 152010: 182011: 152012: 122013: 82014: 112015: 122016: 32017: 62018: 122019: 42020: 52021: 22022: 62023: 42024: 22025: 62026 (partial year): 2
2007high 23 (2008) · low 2 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTL

30in 2025

2007: 92 days median2008: 114 days median2009: 97 days median2010: 132 days median2011: 90 days median2012: 213 days median2013: 90 days median2014: 70 days median2015: 121 days median2016: 186 days median2017: 132 days median2018: 105 days median2019: 99 days median2020: 138 days median2022: 195 days median2023: 29 days median2025: 30 days median
2007high 213 (2012) · low 29 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FTL

1in 2020

2007: 22008: 12009: 12010: 122011: 82012: 22013: 12014: 32017: 12018: 12020: 1
2007high 12 (2010) · low 0 (2015)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FTL

3,487in 2025

2007: 1,7372008: 1,5692009: 1,9062010: 2,1752011: 3,6082012: 14,7002013: 26,5192014: 2,6832015: 2,5262016: 2,4172017: 3,9472018: 11,8932019: 21,7242020: 18,8192021: 16,2842022: 11,4392023: 8,0252024: 8,5652025: 3,487
2007high 26,519 (2013) · low 1,569 (2008)2025

MAUDE reports naming product code FTL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007209221,737
20082311411,569
2009159711,906
201018132122,175
2011159083,608
201212213214,700
2013890126,519
2014117032,683
20151212102,526
2016318602,417
2017613213,947
201812105111,893
2019499021,724
20205138118,819
20212—016,284
20226195011,439
202342908,025
20242—08,565
202563003,487
20262—0—

More from Davol, Inc.

91 FDA decisions under this applicant name. See the company

  • P050038/S044Arista™ AHDavol, Inc. · 2026
  • P050038/S043Arista™ AHDavol, Inc. · 2026
  • K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc. · 2025
  • K250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, Inc. · 2025
  • P050038/S042Arista AHDavol, Inc. · 2024

Recent decisions in FTL

The FTL category page

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  • K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production · 2026
  • K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production · 2025
  • K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc. · 2025
  • K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc. · 2025

https://510kreport.com/device/K003323 · printed Nov 5, 2026

Cite this page

510(k) Report. “K003323: Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003323

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026